AccessGUDID - DEVICE: PILLING (24026704507492)

GUDID

Device Identifier (DI) Information

Brand Name: PILLING
Version or Model: IPN002391
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 070522
Company Name: TELEFLEX INCORPORATED

Primary DI Number: 24026704507492
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 002348191 *Terms of Use

Device Description: ADENOTOME BLADES MEDIUM 2

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:	No
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?
35836	Adenotome blade, reusable	A surgical cutting edge that is designed to be mounted into the handle of an adenotome to excise the adenoids (hypertrophic lymphoid tissue in the nasopharynx) during an adenoidectomy. The device is typically a flat piece of metal (e.g., stainless steel) with one or both sharp edges at the working end; it is configured at its proximal end to attach to a particular type of adenotome. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KBH	ADENOTOME

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

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

Sterilization Method [?]
Moist Heat or Steam Sterilization

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Width: 15.74 Millimeter
Length: 53 Millimeter

Device Record Status

Public Device Record Key: 7b186b05-f586-4514-a934-e5dab8fe34df
Public Version Date: January 18, 2021
Public Version Number: 2
DI Record Publish Date: September 15, 2018

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
No Package DIs found

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: Yes
DM DI Number: 04026704507498
CLOSE

Production Identifier(s) in UDI

[?]

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

Customer Contact

[?]

Phone: +1(919)544-8000
Email: CS@TELEFLEX.COM

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