AccessGUDID - DEVICE: VERSALOK (10886705001163)

GUDID

Device Identifier (DI) Information

Brand Name: VERSALOK
Version or Model: 210800
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 210800
Company Name: Medos International Sàrl

Primary DI Number: 10886705001163
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 482661753 *Terms of Use

Device Description: Versalok Anchor with Threader Tab

Device Characteristics

What MRI safety information does the labeling contain?	MR Conditional
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?
45062	Tendon/ligament bone anchor, non-bioabsorbable	A non-bioabsorbable device designed to be implanted into bone for the attachment of tendons/ligaments/soft tissues either directly or via a suture attached to the device; typically used in arthroscopic or open surgical procedures. This device is available in various designs and sizes and is made of a material that cannot be chemically degraded or absorbed via natural body processes [e.g., titanium (Ti)].	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
MBI	Fastener, fixation, nondegradable, soft tissue
NEW	Suture, surgical, absorbable, polydioxanone
GAT	Suture, nonabsorbable, synthetic, polyethylene
GAM	Suture, absorbable, synthetic, polyglycolic acid
HWC	Screw, fixation, bone
GAS	Suture, nonabsorbable, synthetic, polyester

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K063478	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: Yes

Sterilization Method [?]
Ethylene Oxide

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: 18072026-4d73-4a70-9999-07a262498b4b
Public Version Date: May 08, 2025
Public Version Number: 1
DI Record Publish Date: April 30, 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: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

No Customer Contact currently defined

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

FDA TOOLS & RESOURCES