Company Name Brand Name GMDN Term Name GMDN Term Status FDA Product Code Name FDA Product Code Device Packaged As Sterile Sterilization Prior To Use Issuing Agency Device Size Device Size Type Device Class Implantable

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For Use with PakAuto
IMMUCOR GTI DIAGNOSTICS, INC.
404560
Not in Commercial Distribution

  • 10888234500476 ()
404560

  • Human platelet antigen (HPA) multiple antibody screening/identification IVD, reagent
For Use with Pak2-LE
IMMUCOR GTI DIAGNOSTICS, INC.
404558
Not in Commercial Distribution

  • 10888234500469 ()
404558

  • Human platelet antigen (HPA) multiple antibody screening/identification IVD, reagent
For Use with Pak12G
IMMUCOR GTI DIAGNOSTICS, INC.
404557
Not in Commercial Distribution

  • 10888234500452 ()
404557

  • Human platelet antigen (HPA) multiple antibody screening/identification IVD, reagent
Eon Desensitizer with Glutaraldehyde
BENCO DENTAL SUPPLY CO.
5146-567
In Commercial Distribution

  • 00366975013323 ()


  • Dental coating, tooth-desensitizing
HANDLE WITH QUICK COUPLING
ELMED INCORPORATED
23-31143
In Commercial Distribution

  • 00842180172722 ()
23-31143

  • Arthroscopic surgical procedure kit, non-medicated, reusable
Bi-Mask with silicone lip
VBM Medizintechnik GmbH
35-65-222
In Commercial Distribution

  • 04250105620184 ()


  • Anaesthesia face mask, reusable
Biteblock with elastic necktape
VBM Medizintechnik GmbH
40-76-050
In Commercial Distribution

  • 14250105605515 ()
  • 04250105605518 ()

  • #5 ; suitable for ET Tubes: 8.5 - 11.0 mm / Laryngeal Tubes: LT / LTS II #2, #2.5 / Laryngeal Masks: # 2, #2.5


  • Oropharyngeal airway, reusable
Biteblock with elastic necktape
VBM Medizintechnik GmbH
40-76-060
In Commercial Distribution

  • 14250105605508 ()
  • 04250105605501 ()

  • #6 ; suitable for Laryngeal Tubes: LT / LTS II #3, #4, #5 / Laryngeal Masks: #3, #4, #5


  • Oropharyngeal airway, reusable
Bi-Mask with silicone lip
VBM Medizintechnik GmbH
35-65-226
In Commercial Distribution

  • 04250105608854 ()

  • #6 ; 22 mm I.D.


  • Anaesthesia face mask, reusable
Bi-Mask with silicone lip
VBM Medizintechnik GmbH
35-65-225
In Commercial Distribution

  • 04250105608847 ()

  • #5 ; 22 mm I.D.


  • Anaesthesia face mask, reusable
Bi-Mask with silicone lip
VBM Medizintechnik GmbH
35-65-224
In Commercial Distribution

  • 04250105608830 ()

  • #4 ; 22 mm I.D.


  • Anaesthesia face mask, reusable
Bi-Mask with silicone lip
VBM Medizintechnik GmbH
35-65-223
In Commercial Distribution

  • 04250105608823 ()

  • #3 ; 22 mm I.D.


  • Anaesthesia face mask, reusable
Pudenz Catheter with Stylet
NATUS MEDICAL INCORPORATED
NT8501228
In Commercial Distribution


  • Tubing: 1.3mm I.D. x 2.5mm O.D.; Total Length: 18cm (7") (all dimensions nominal)
NT8501228

  • Intracerebral infusion/drainage catheter, long-term
RetCam Envision with FA
XLTEK
61-000300
In Commercial Distribution

  • 00382830056335 ()


  • Ophthalmic fundus camera
Inserter with Stop Instrument
ALLIANCE PARTNERS LLC
1412T-400-S
In Commercial Distribution

  • M6861412T400S0 ()
1412T-400-S

  • Orthopaedic inorganic implant inserter/extractor, reusable
LAMINECTOMY WITH BASIN PK
Cardinal Health 200, LLC
SNE69LMEC1
In Commercial Distribution

  • 50888439092361 ()
  • 10888439092363 ()
SNE69LMEC1

  • Neurosurgical procedure kit, non-medicated, single-use
with Control-IQ 7.X
Tandem Diabetes Care, Inc.
1013117
In Commercial Distribution

  • 00389152311777 ()


  • Ambulatory insulin infusion pump, electronic, software-dosing, scalar algorithm
Senti device with touchscreen
PATH medical GmbH
100097
Not in Commercial Distribution

  • 04260223142529 ()


  • Tone audiometer
BESS Tray with lid
Hoogland Spine Products GmbH
1001-IS 014
In Commercial Distribution

  • 04260200313867 ()


  • Instrument tray, reusable
MaxDisc Tray with lid
Hoogland Spine Products GmbH
1001-IS 011
In Commercial Distribution

  • 04260200312631 ()


  • Instrument tray, reusable
Curette with Fibre Handle
GPC MEDICAL LIMITED
COG803
In Commercial Distribution

  • 08904400200027 ()


  • General external orthopaedic fixation system implantation kit, reusable
KIT, RECOVERY WITH PILLOW
Cardinal Health 200, LLC
OMS4401323
In Commercial Distribution

  • 50888439006504 ()
  • 10888439006506 ()
OMS4401323

  • General surgical procedure kit, non-medicated, single-use
BIRD BEAK WITH CUTTER
COLTENE/WHALEDENT INC
D139C
Not in Commercial Distribution

  • D661D139C0 ()


  • Orthodontic pliers
CVAD WITH PVP KIT
MEDLINE INDUSTRIES, INC.
DYNDC1976B
In Commercial Distribution

  • 10888277519855 ()
DYNDC1976B

  • General surgical procedure kit, non-medicated, reusable
BASIN PACK WITH GOWNS
MEDLINE INDUSTRIES, INC.
DYNJ44070
In Commercial Distribution

  • 10888277082939 ()
DYNJ44070

  • General surgical procedure kit, non-medicated, reusable
with scale, 92x54 mm
Spiggle & Theis Medizintechnik GmbH
10-735-00
In Commercial Distribution

  • 04250381850169 ()
10-735-00

  • Surgical cutting/shaping board, reusable
KNEE ARTHROSCOPY WITH POUCH
Cardinal Health 200, LLC
SOPOCKNWMB
In Commercial Distribution

  • 50887488633167 ()
  • 10887488633169 ()
SOPOCKNWMB

  • Arthroscopic surgical procedure kit, medicated
CATARACT WITH TUBING PACK
Cardinal Health 200, LLC
SEY44CAASA
In Commercial Distribution

  • 50887488546870 ()
  • 10887488546872 ()
SEY44CAASA

  • Ophthalmic surgical procedure kit, medicated, single-use
ARTHROSCOPY WITH OIL DRESS
Cardinal Health 200, LLC
SOP48APPSF
In Commercial Distribution

  • 50887488539414 ()
  • 10887488539416 ()
SOP48APPSF

  • Arthroscopic surgical procedure kit, medicated
TOTAL JOINT WITH BASIN
Cardinal Health 200, LLC
SOP69TJECD
In Commercial Distribution

  • 50887488624929 ()
  • 10887488624921 ()
SOP69TJECD

  • Orthopaedic surgical procedure kit, non-medicated, single-use
Awl with Sleeve, Angled
CTL Medical Corporation
120.7702
In Commercial Distribution

  • 00841732142336 ()


  • General internal orthopaedic fixation system implantation kit
Awl with Sleeve, Straight
CTL Medical Corporation
120.7701
In Commercial Distribution

  • 00841732142329 ()


  • General internal orthopaedic fixation system implantation kit
Intraoral X-ray with Handswitch
MIDMARK CORPORATION
PE7017-D
In Commercial Distribution

  • 00841709103452 ()
PE7017-D

  • Stationary intraoral dental x-ray system, digital
Intraoral X-ray with Handswitch
MIDMARK CORPORATION
PE7016-D
In Commercial Distribution

  • 00841709103407 ()
PE7016-D

  • Stationary intraoral dental x-ray system, digital
Intraoral X-ray with Handswitch
MIDMARK CORPORATION
PE7015-D
In Commercial Distribution

  • 00841709103353 ()
PE7015-D

  • Stationary intraoral dental x-ray system, digital
ROBOTIC KIT WITH AIRSEAL
Cardinal Health 200, LLC
PGOCLPMMB
In Commercial Distribution

  • 50887488599456 ()
  • 10887488599458 ()
PGOCLPMMB

  • General surgical procedure kit, non-medicated, single-use
Filters with Solution Spike
HAEMONETICS CORPORATION
CPS02
In Commercial Distribution

  • 30887691000301 ()
  • 10887691000307 ()


  • Blood donor set, single-pack
Rod Reducer with Handle
Zavation LLC
10-1039
In Commercial Distribution

  • 00842166176188 ()


  • Internal spinal fixation procedure kit, reusable
FILE WITH HEX COUPLING
Synthes GmbH
03.500.020
In Commercial Distribution

  • H980035000200 ()
  • 10887587010403 ()
03500020

  • Bone file/rasp, manual, reusable
CIF Rasp with Stop
Zavation LLC
ZAV-1004
In Commercial Distribution

  • 00842166185111 ()


  • Polymeric spinal interbody fusion cage
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