AccessGUDID - DEVICE: CUSTOMED (M20890022008100)

GUDID

Device Identifier (DI) Information

Brand Name: CUSTOMED
Version or Model: 712057830810
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 9002200810
Company Name: CUSTOMED INC

Primary DI Number: M20890022008100
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 627572217 *Terms of Use

Device Description: CUSTOMED J-MAX DIAMOND TIP BIOPSY NEEDLE, 8G X 100MM, DARK GREEN

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
46350	Bone marrow biopsy needle, single-use	A sterile, sharp bevel-edged, hollow tubular metal instrument designed to obtain a specimen of bone marrow percutaneously. The device is typically available in a variety of large bores, and is sufficiently robust to penetrate bone (usually the hip bone or posterior iliac crest) with the force of pressure and twisting manually applied to its proximal handgrip. The resultant specimen is typically used for the pathological analysis of the source of blood cellular elements. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KNW	Instrument, Biopsy

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K092338	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Special Storage Condition, Specify: Sterile if package is unopened or undamaged.
Special Storage Condition, Specify: Keep in a cool, dry place, away from heat and light sources.

Clinically Relevant Size

[?]

Size Type Text
Length: 100 Millimeter
Needle Gauge: 8 Gauge

Device Record Status

Public Device Record Key: 22757295-2a29-4b28-90a3-f3e41cc31fc7
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: September 23, 2016

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
M20890022008101	10	M20890022008100		In Commercial Distribution	10/BOX

Secondary DI

[?]

Issuing Agency [?]	Secondary DI Number
No Secondary DIs found

Unit of Use DI

[?]

Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]

Device Subject to Direct Marking (DM), but Excepted: No
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Production Identifier(s) in UDI

[?]

Lot or Batch Number: Yes
Serial Number: No
Expiration Date: Yes
Manufacturing Date: Yes
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: 787-622-5151
Email: customer.service@customedhealing.com

MENU
- Home
- About
- News
- API
- Download
- Help

FDA TOOLS & RESOURCES