AccessGUDID - DEVICE: ComposiTCP (03760154006934)

GUDID

Device Identifier (DI) Information

Brand Name: ComposiTCP
Version or Model: ComposiTCP 30 round head
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 905238
Company Name: S.B.M

Primary DI Number: 03760154006934
Issuing Agency: GS1
Commercial Distribution End Date: July 20, 2022
Device Count: 1
Labeler D-U-N-S® Number*: 772462123 *Terms of Use

Device Description: Absorbable interference screw

Device Characteristics

What MRI safety information does the labeling contain?	MR Safe
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?
45039	Bioabsorbable orthopaedic bone screw	A small, threaded, implantable rod with a slotted head typically used for internal orthopaedic fracture fixation by being screwed into bone to hold plates or nails to bone or to provide direct interfragmentary stabilization of bone, or it may fasten soft tissue to bone; it is made of a material that is chemically degraded and typically absorbed via natural body processes (e.g., degradable polymers). There are several kinds available: cortical, cancellous, malleolar, scaphoid, partially-threaded and fully-threaded. A "lag screw" can be any of these used to obtain compression across bone fragments.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
MAI	Fastener, Fixation, Biodegradable, Soft Tissue

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K090994	000
K122228	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
Storage Environment Temperature: less than 33 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
Length: 20 Millimeter
Outer Diameter: 9 Millimeter

Device Record Status

Public Device Record Key: e78878d1-2f41-47bd-bf88-4648ad31864c
Public Version Date: January 03, 2024
Public Version Number: 8
DI Record Publish Date: September 23, 2015