AccessGUDID - DEVICE: RapidSorb (10887587064239)

GUDID

Device Identifier (DI) Information

Brand Name: RapidSorb
Version or Model: 851.801.01S
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 85180101S
Company Name: Synthes GmbH

Primary DI Number: 10887587064239
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 486711679 *Terms of Use

Device Description: RAPID RESORBABLE CRANIAL CLAMP 18MM

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?
46639	Craniofacial bone tack, bioabsorbable	A small, bioabsorbable, cylindrical shaft, typically with a flat, rounded head at one end and tapered to a point at the other, intended to be implanted into craniofacial bone (includes maxilla and/or mandible) to provide stabilization for fracture repair and reconstructive procedures (e.g., dental regeneration membrane fixation), or to maintain the relative position of bony fragments, bone grafts, or bone graft substitutes. It is made of a material that is chemically degraded and typically absorbed via natural body processes (e.g., a degradable polymer), and may be designed to be heated during implantation, with a dedicated inserter, to facilitate its moulding and optimal insertion.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
GXR	COVER, BURR HOLE
HBW	FASTENER, PLATE, CRANIOPLASTY

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K041611	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
Special Storage Condition, Specify: .
Storage Environment Temperature: between 5 and 25 Degrees Celsius
Handling Environment Temperature: less than 43 Degrees Celsius
Storage Environment Temperature: between 41 and 77 Degrees Fahrenheit
Handling Environment Temperature: less than 110 Degrees Fahrenheit

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 7963d9d9-35cb-4c0d-91c6-6ff3e485f3ae
Public Version Date: November 13, 2024
Public Version Number: 7
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	H98085180101S0

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

[?]

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

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