FDA.report

T5 3-0 Und Br Pga 27"/70cm

Primary DI
10848782014290
Brand
T5 3-0 Und Br Pga 27"/70cm
Company
Surgical Specialties México, S. de R.L. de C.V.
Model
G232N
Catalog number
G232
Device description
T5 3-0 Und Br Pga 27"/70cm
Published
2015-10-21
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

Contact Domains

Product Codes

CodeName
GAMSUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID

Product Code Classifications

CodeDeviceSpecialtyClass
GAMSuture, Absorbable, Synthetic, Polyglycolic AcidGeneral, Plastic Surgery2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
10848782014290PackageGS112In Commercial Distribution
00848782014293PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
1084878201429010848782014290
00848782014293008487820142938487820142930848782014293

GMDN Terms

TermDefinition
Polyglycolic acid sutureA sterile, typically multiple-strand (multifilament), synthetic, bioabsorbable thread made from a polymerization of polyglycolic acid (PGA) that is intended to join (approximate) the edges of a soft-tissue wound or incision by stitching or to ligate soft tissues. It may include an attached needle intended to be disposed of after single use; it may be coated with a material such as polycaprolactone or uncoated. The thread provides temporary wound support, until the wound sufficiently heals to withstand normal stress, and is subsequently absorbed by hydrolysis. This is a single-use device.

Device Sizes

TypeValueUnit
Device Size Text, specify0

Sterilization Methods

Method

Contacts

PhoneEmail
+1(877)991-1110service@surgicalspecialties.com

Regulatory Flags

DUNS number
812762226
Device count
1
DM exempt
true
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

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