AccessGUDID - DEVICE: NA (10886982197832)

GUDID

Device Identifier (DI) Information

Brand Name: NA
Version or Model: 390.006
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 390006
Company Name: Synthes GmbH

Primary DI Number: 10886982197832
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 486711679 *Terms of Use

Device Description: LRG EX-FIX DYNAMIZATION CLAMP F/COMBO CLAMP / MR-CONDITIONAL

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?
10904	Surgical instrument clip	A device designed to hold surgical instruments together; typically those with ring handles. This can be for sterilization, storage purposes, and/or to keep surgical instruments used for a particular procedure together prior to being lain out for surgery. It is typically designed like a very large safety pin (i.e., an elongated spring wire clasp with a locking catch onto which the instruments are threaded, usually by the ring handle). It is typically made of stainless steel or chromed metal. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KTT	APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT
LXT	APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT, METAL COMPOSITE

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K030390	000
K033158	000
K082650	000
K122455	000

Device Exempt from Premarket Submission: No 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: 70825a83-2c6d-43fa-ae85-68a6f5655855
Public Version Date: January 31, 2023
Public Version Number: 6
DI Record Publish Date: September 14, 2015

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	H6793900060

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: 07611819758421
CLOSE

Production Identifier(s) in UDI

[?]

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

Customer Contact

[?]

Phone: +1(800)255-2500
Email: xx@xx.xx

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

FDA TOOLS & RESOURCES