AccessGUDID - DEVICE: Universal Tendon Spacer (03700751502132)

GUDID

Device Identifier (DI) Information

Brand Name: Universal Tendon Spacer
Version or Model: 0232-01-00
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: ASKORN MEDICAL

Primary DI Number: 03700751502132
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 289183779 *Terms of Use

Device Description: No description.

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?
35276	Tendon sheath regeneration implant	A device intended to be implanted to temporarily aid growth of a new tendon sheath for tendon reconstruction. It is made of synthetic polymer (e.g., a silicone elastomer or polyester-reinforced silicone elastomer) and/or metal materials.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
HXA	Prosthesis, Tendon, Passive

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K243477	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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 1309ef54-50b7-40b9-8b70-762462c36028
Public Version Date: April 28, 2025
Public Version Number: 1
DI Record Publish Date: April 20, 2025

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: 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

[?]

No Customer Contact currently defined

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