FDA.reportPublic FDA data

FSSB

Primary DI
10848782029935
Brand
FSSB
Company
Surgical Specialties México, S. de R.L. de C.V.
Model
A030PP
Device description
GLZ-16.0-170 dlz-4.2-100 usp 10/0 pp 10
Published
2022-08-01
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GAMSUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID
GAWSuture, Nonabsorbable, Synthetic, Polypropylene

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GAMSuture, Absorbable, Synthetic, Polyglycolic AcidGeneral, Plastic Surgery2
GAWSuture, Nonabsorbable, Synthetic, PolypropyleneGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K131224000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K131224000SHARPOINT POLYPROPYLENE SURGICAL SUTURE, LOOK POLYPROPYLENE SURGICAL SUTURE, QUILL POLYPROPYLENE KNOTLESS TISSUE-CLOSURESurgical Specialties Corp. Dba Angiotech2013-05-16GAW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10848782029935PackageGS112In Commercial Distribution
00848782029938PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1084878202993510848782029935
00848782029938008487820299388487820299380848782029938

GMDN Terms#

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

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00848782052455SharpointC926N2026-08-26
00848782052516SharpointA1702N2026-08-26
00848782052417SharpointB915N2026-07-06
00848782052424SharpointB926N2026-07-06
00848782052431SharpointB937N2026-07-06
00848782052448SharpointB948N2026-07-06
00848782052462SharpointC937N2026-07-06
00848782052486SharpointC959N2026-07-06
00848782052493SharpointM952N2026-07-06
00848782052509SharpointM963N2026-07-06
00848782052684SharpointB930N2026-07-06
00848782052691SharpointB931N2026-07-06
00848782052707SharpointC960N2026-07-06
00848782052714SharpointB932N2026-07-06
00848782052721SharpointB933N2026-07-06
00848782052738SharpointC961N2026-07-06
00848782052745SharpointC962N2026-07-06
00848782052752SharpointC963N2026-07-06
00848782052776SharpointC965N2026-07-06
00848782052783SharpointB934N2026-07-06

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08903837224453MonoglydeHEALTHIUM MEDTECH LIMITEDGAM2026-08-19
08903837224491MonoglydeHEALTHIUM MEDTECH LIMITEDGAM2026-08-19
08903837224514TruleneHEALTHIUM MEDTECH LIMITEDGAW2026-08-19
08903837224538TruleneHEALTHIUM MEDTECH LIMITEDGAW2026-08-19
08903837224552TruleneHEALTHIUM MEDTECH LIMITEDGAW2026-08-19
08903837337214MonoglydeHEALTHIUM MEDTECH LIMITEDGAM2026-08-19
08903837337238TruleneHEALTHIUM MEDTECH LIMITEDGAW2026-08-19
08903837337252PDSYNTHHEALTHIUM MEDTECH LIMITEDGAM2026-08-19
08903837402349TruglydeHEALTHIUM MEDTECH LIMITEDGAM2026-08-19
08903837799265MonoglydeHEALTHIUM MEDTECH LIMITEDGAM2026-08-19
08903837799289MonoglydeHEALTHIUM MEDTECH LIMITEDGAM2026-08-19
08903837799302MonoglydeHEALTHIUM MEDTECH LIMITEDGAM2026-08-19
10705031471863VICRYLETHICON, LLCGAM2026-08-19
10705031472150Coated VICRYLETHICON, LLCGAM2026-08-19
10705031472167Coated VICRYLETHICON, LLCGAM2026-08-19
10705031472211VICRYLETHICON, LLCGAM2026-08-19
10705031472228VICRYLETHICON, LLCGAM2026-08-19
10705031091412PROLENEETHICON, LLCGAW2026-08-17
10705031091467PROLENEETHICON, LLCGAW2026-08-17
10705031091474PROLENEETHICON, LLCGAW2026-08-17
10705031091764PROLENEETHICON, LLCGAW2026-08-17
10705031095045PROLENEETHICON, LLCGAW2026-08-17
10705031095359PROLENEETHICON, LLCGAW2026-08-17
10705031096325PROLENEETHICON, LLCGAW2026-08-17
10705031097278PROLENEETHICON, LLCGAW2026-08-17
10705031097643PROLENEETHICON, LLCGAW2026-08-17
10705031097698PROLENEETHICON, LLCGAW2026-08-17
10705031097896PROLENEETHICON, LLCGAW2026-08-17
10705031097919PROLENEETHICON, LLCGAW2026-08-17
10705031097995PROLENEETHICON, LLCGAW2026-08-17