AccessGUDID - DEVICE: Inion ACL™ Instrumentation (06438408002861)

GUDID

Device Identifier (DI) Information

Brand Name: Inion ACL™ Instrumentation
Version or Model: 1
Commercial Distribution Status: In Commercial Distribution
Catalog Number: INS-9352
Company Name: Inion Oy

Primary DI Number: 06438408002861
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 367994657 *Terms of Use

Device Description: Soft tissue clamp, adjustable

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?
56651	Tendon/ligament graft preparation station post	A component of a graft preparation station designed to be affixed to the station base to help position, clamp and tension a ligament and/or tendon graft being prepared for implantation. This device is typically made of high-grade stainless steel and is available in a variety of sizes and types such as adjustable or fixed graft posts, patellar tendon posts, soft tissue clamp posts, and tensioning posts. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
HXD	CLAMP

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
No Device Sizes

Device Record Status

Public Device Record Key: 5a833270-2c9d-4fd8-a90e-d52dd2ff74c7
Public Version Date: January 27, 2025
Public Version Number: 3
DI Record Publish Date: May 08, 2020

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
HIBCC	M224INS93529

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: No
Manufacturing Date: Yes
Donation Identification Number: No CLOSE

Customer Contact

[?]

No Customer Contact currently defined

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