FDA.report

POLYBOND®

Primary DI
20790986006755
Brand
POLYBOND®
Company
C.P. MEDICAL CORPORATION
Model
CP663A
Published
2017-04-13
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Related Records

Product Codes

CodeName
GATSuture, Nonabsorbable, Synthetic, Polyethylene

Product Code Classifications

CodeDeviceSpecialtyClass
GATSuture, Nonabsorbable, Synthetic, PolyethyleneGeneral, Plastic Surgery2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
20790986006755PackageGS112In Commercial Distribution
10790986006895PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
2079098600675520790986006755
1079098600689510790986006895

GMDN Terms

TermDefinition
Polyester suture, non-bioabsorbable, multifilamentA multiple-strand (multifilament), synthetic thread made from a non-bioabsorbable polyester 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

Regulatory Flags

DUNS number
807404611
Device count
1
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 DIBrandModelCatalogPublished
00790986000001CP Cotton Umbilical TapeCP10A2024-03-29
00790986000551CP Cotton Umbilical TapeCP11A2015-09-24
00790986000568CP Cotton Umbilical TapeCP12A2015-09-24
20790986000555CP Cotton Umbilical TapeCP11A2015-09-24
20790986006298FN NEEDLESFN18-51TFN18-51T2016-02-19
20790986006304FN NEEDLESFN18-3TFN18-3T2016-02-19
20790986006311FN NEEDLESFN18-1TFN18-1T2016-02-19
20790986006328FN NEEDLESFN17-51TFN17-51T2016-02-19
20790986006335FN NEEDLESFN17-3TFN17-3T2016-02-19
20790986006342FN NEEDLESFN17-1TFN17-1T2016-02-19
20790986006878FN NEEDLESFN18-53T2017-11-06
10790986001005MONO-DOXM1842016-07-26
20790986001019MONO-DOXM3042016-07-26
20790986001026MONO-DOXM305M3052016-06-13
20790986001033MONO-DOXM310M3102016-06-13
20790986001040MONO-DOXM311M3112016-06-13
20790986001057MONO-DOXM3152016-07-26
20790986001071MONO-DOXM317M3172016-07-26
20790986001088MONO-DOXM332M3322016-06-13
20790986001095MONO-DOXM333M3332016-06-13

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00840277411068HS FiberRIVERPOINT MEDICAL, LLCGAT2026-01-26
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00888867459205Arthrex®ARTHREX, INC.GAT2025-12-26
00888867459212Arthrex®ARTHREX, INC.GAT2025-12-26
00810129092271HyperSutureThreadstone LLCGAT2025-12-09