AccessGUDID - DEVICE: CFCPX (00857915007019)

GUDID

Device Identifier (DI) Information

Brand Name: CFCPX
Version or Model: 8800-81
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: A.M. SURGICAL, INC.

Primary DI Number: 00857915007019
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 160020087 *Terms of Use

Device Description: Carbon Fiber CPX

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":	Yes
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?
48012	External orthopaedic fixation system, single-use, sterile	An assembly of sterile devices designed to stabilize fractured bones of the lower limbs to promote treatment and healing. It typically consists of an external plastic and/or metallic fixator (a framework) and other external and/or implantable components such as clamps, rods, rings, pins, bolts, and nuts, as well as some reusable instrumentation (e.g., wrenches, depth gauge, tensioner). It is used mainly to help the healing of long bones such as the femur and tibia, as well as fractures of the foot and ankle, joint fusions, and limb lengthening. This is a single-use device.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
LXT	Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, Metal Composite

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K042458	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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 57aaa30e-f285-4357-a1c5-b357b0318648
Public Version Date: May 16, 2019
Public Version Number: 2
DI Record Publish Date: September 03, 2018

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
00857915007392	1	00857915007019		In Commercial Distribution	Kit

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

[?]

Phone: 6319799777
Email: service@amsurgical.com

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