AccessGUDID - DEVICE: NA (20887587039227)

GUDID

Device Identifier (DI) Information

Brand Name: NA
Version or Model: 329.148.05
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 32914805
Company Name: Synthes GmbH

Primary DI Number: 20887587039227
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 5
Labeler D-U-N-S® Number*: 486711679 *Terms of Use

Device Description: REPLACEMENT PL-HOLDING INSERT F/MANDIBLE PL BENDER/CUTTERS

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?
47730	Bone fixation plate pliers insert	A small, soft, gripping device inserted into bone fixation plate bending/cutting pliers to hold the free section of a cut implant to prevent it from becoming a projectile when it is cut. The insert is used when modifying an orthopaedic implant, typically a light bone plate [e.g., a 1-2 mm in thickness craniomaxillofacial (CMF) fixation plate being cut to a desired length]. It is typically made of synthetic material (e.g., silicone). This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
HXP	INSTRUMENT, BENDING OR CONTOURING

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: 27b398c2-98dd-4a91-9288-61ff87856cfb
Public Version Date: April 25, 2022
Public Version Number: 3
DI Record Publish Date: December 31, 2016

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	H980329148050

Unit of Use DI

[?]

Unit of Use DI Number: 80887587039229 CLOSE

Direct Marking (DM)

[?]

Device Subject to Direct Marking (DM), but Excepted: Yes
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: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

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

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