FDA.reportPublic FDA data

CP FIBER

Primary DI
20790986004683
Brand
CP FIBER
Company
C.P. MEDICAL CORPORATION
Model
ST653
Catalog number
ST653
Published
2015-12-21
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
GATSuture, Nonabsorbable, Synthetic, Polyethylene

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GATSuture, Nonabsorbable, Synthetic, PolyethyleneGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K041894000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K041894000ORTHOFIBERCp Medical2004-09-17GAT

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20790986004683PackageGS112In Commercial Distribution
10790986004686PrimaryGS10
00000000000000Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2079098600468320790986004683
1079098600468610790986004686
00000000000000000000000000000000000000000000000000000

GMDN Terms#

Term, Definition table
TermDefinition
Polyolefin suture, multifilamentA multiple-strand (multifilament), synthetic, non-bioabsorbable thread made of a polyolefin (e.g., polyethylene) intended to join (i.e., approximate) the edges of a soft-tissue wound or incision by stitching or to ligate soft tissues; it may include an attached disposable device(s) [e.g., needle, passer] intended to facilitate suture application. The thread provides temporary wound support until the wound sufficiently heals to withstand normal stress. It is not a barbed suture and does not include antimicrobial agents/materials. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
807404611
Device count
4
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10790986004181POLYBONDCP24A2015-09-24
10790986004198POLYBONDCP25A2015-09-24
10790986004204POLYBONDCP34A2015-09-24
10790986004211POLYBONDCP35A2015-09-24
10790986004228POLYBONDCP43ACP43A2015-12-21
10790986004235POLYBONDCP52ACP52A2015-12-21
10790986004242POLYBONDCP54ACP54A2015-12-21
10790986004259POLYBONDCP58SA2015-09-24
10790986004266POLYBONDCP77ACP77A2015-12-21
10790986004273POLYBONDCP88A2015-09-24
10790986004280POLYBONDCP513A2015-09-24
10790986004297POLYBONDCP23A2015-09-24
10790986004303POLYBONDCP553A2015-09-24
10790986004310POLYBONDCP557A2015-09-24
10790986004327POLYBONDCP558A2015-09-24
10790986004334POLYBONDCP563A2015-09-24
10790986004341POLYBONDCP581A2015-09-24
10790986004358POLYBONDCP588A2015-09-24
10790986004365POLYBONDCP664A2015-09-24
10790986004372POLYBONDCP683A2015-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10705031097414MERSILENEETHICON, LLCGAT2026-08-17
00860424000273SpeedGraft QuadLink TendonJOINT RESTORATION FOUNDATION INCGAT2024-07-15
00860424000280PilotGraft BTB Tendon, 9 mmJOINT RESTORATION FOUNDATION INCGAT2024-07-15
00860424000297PilotGraft BTB Tendon, 11 mmJOINT RESTORATION FOUNDATION INCGAT2024-07-15
00191083047676RapidEase™Rti Surgical, Inc.GAT2023-11-03
00191083047683RapidEase™Rti Surgical, Inc.GAT2023-11-03
00860424000266SpeedGraft Achilles TendonJOINT RESTORATION FOUNDATION INCGAT2022-08-31
00860424000259JRF PilotGraft BTBJOINT RESTORATION FOUNDATION INCGAT2021-04-02
00860424000242JRF VersaGraft 3.5JOINT RESTORATION FOUNDATION INCGAT2018-09-18
14026704426260DEKNATELTELEFLEX INCORPORATEDGAT2017-04-19
14026704427250DEKNATELTELEFLEX INCORPORATEDGAT2017-04-19
00860424000235JRF GraftLink XLJOINT RESTORATION FOUNDATION INCGAT2016-03-30
00889858118491FlexiGRAFT®LIFENET HEALTHGAT2015-09-24
00889858117111FlexiGRAFT®LIFENET HEALTHGAT2015-09-24
00889858117135FlexiGRAFT®LIFENET HEALTHGAT2015-09-24
00889858117159FlexiGRAFT®LIFENET HEALTHGAT2015-09-24
00889858117173FlexiGRAFT®LIFENET HEALTHGAT2015-09-24
00889858117210FlexiGRAFT®LIFENET HEALTHGAT2015-09-24
00889858117234FlexiGRAFT®LIFENET HEALTHGAT2015-09-24
00889858117258FlexiGRAFT®LIFENET HEALTHGAT2015-09-24
00889858117296FlexiGRAFT®LIFENET HEALTHGAT2015-09-24
00889858117333FlexiGRAFT®LIFENET HEALTHGAT2015-09-24
00889858117357FlexiGRAFT®LIFENET HEALTHGAT2015-09-24
00889858117371FlexiGRAFT®LIFENET HEALTHGAT2015-09-24
00889858117432FlexiGRAFT®LIFENET HEALTHGAT2015-09-24
00889858117456FlexiGRAFT®LIFENET HEALTHGAT2015-09-24
00889858117494FlexiGRAFT®LIFENET HEALTHGAT2015-09-24
00889858117517FlexiGRAFT®LIFENET HEALTHGAT2015-09-24
00889858117555FlexiGRAFT®LIFENET HEALTHGAT2015-09-24
00889858117579FlexiGRAFT®LIFENET HEALTHGAT2015-09-24