FDA.reportPublic FDA data

Hsm16 5-0 Bk Mono Nyl 18"/45cm

Primary DI
10848782009975
Brand
Hsm16 5-0 Bk Mono Nyl 18"/45cm
Company
Surgical Specialties México, S. de R.L. de C.V.
Model
A1661N
Catalog number
A1661
Device description
Hsm16 5-0 Bk Mono Nyl 18"/45cm
Published
2015-10-20
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

Contact Domains#

Product Codes#

Code, Name table
CodeName
GARSUTURE, NONABSORBABLE, SYNTHETIC, POLYAMIDE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GARSuture, Nonabsorbable, Synthetic, PolyamideGeneral, Plastic Surgery2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10848782009975PackageGS112In Commercial Distribution
00848782009978PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1084878200997510848782009975
00848782009978008487820099788487820099780848782009978

GMDN Terms#

Term, Definition table
TermDefinition
Nylon suture, non-bioabsorbable, monofilamentA single-strand (monofilament), synthetic, non-bioabsorbable thread made of nylon (a polyamide polymer) 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 needle intended to be disposed of after single use. The thread provides temporary wound support until the wound sufficiently heals. It is not a barbed suture and does not include antimicrobial agents/materials. This is a single-use device intended to be used in a sterile condition.

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
10848782051516QuillVLP-4160 2025-07-11
00848782051786OnatecOL144091OL1440912025-06-02
00848782051793OnatecOL415691OL4156912025-06-02
00848782051809OnatecOL456291OL4562912025-06-02
10848782051813OnatecON456291ON4562912025-06-02
10848782051820OnatecON245071ON2450712025-06-02
10848782051837OnatecON146571ON1465712025-06-02
10848782051844OnatecON244081ON2440812025-06-02
10848782051851OnatecON454081ON4540812025-06-02
00848782051861OnatecOL145091OL1450912025-06-02
00848782051878OnatecOL415591OL4155912025-06-02
00848782051892OnatecOL145081OL1450812025-06-02
00848782051908OnatecOL415681OL4156812025-06-02
10848782051912OnatecOE261391OE2613912025-06-02
10848782051929OnatecOE471691OE4716912025-06-02
10848782051936OnatecON456671ON4566712025-06-02
10848782051943OnatecOE481691OE4816912025-06-02
10848782051950OnatecOE341331OE3413312025-06-02
00848782051960OnatecOL494891OL4948912025-06-02
00848782051977OnatecOL415592OL4155922025-06-02

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
14946585362283CROWNJUN Nylon SutureKONO SEISAKUSHO CO.,LTD.GAR2026-03-12
14946585362290CROWNJUN Nylon SutureKONO SEISAKUSHO CO.,LTD.GAR2026-03-12
14946585362306CROWNJUN Nylon SutureKONO SEISAKUSHO CO.,LTD.GAR2026-03-12
14946585362313CROWNJUN Nylon SutureKONO SEISAKUSHO CO.,LTD.GAR2026-03-12
14946585362320CROWNJUN Nylon SutureKONO SEISAKUSHO CO.,LTD.GAR2026-03-12
14946585362337CROWNJUN Nylon SutureKONO SEISAKUSHO CO.,LTD.GAR2026-03-12
14946585362344CROWNJUN Nylon SutureKONO SEISAKUSHO CO.,LTD.GAR2026-03-12
14946585362351CROWNJUN Nylon SutureKONO SEISAKUSHO CO.,LTD.GAR2026-03-12
14946585362368CROWNJUN Nylon SutureKONO SEISAKUSHO CO.,LTD.GAR2026-03-12
14946585362375CROWNJUN Nylon SutureKONO SEISAKUSHO CO.,LTD.GAR2026-03-12
14946585362382CROWNJUN Nylon SutureKONO SEISAKUSHO CO.,LTD.GAR2026-03-12
14946585362399CROWNJUN Nylon SutureKONO SEISAKUSHO CO.,LTD.GAR2026-03-12
14946585362405CROWNJUN Nylon SutureKONO SEISAKUSHO CO.,LTD.GAR2026-03-12
14946585362412CROWNJUN Nylon SutureKONO SEISAKUSHO CO.,LTD.GAR2026-03-12
03661522103128CARDIONYL®PETERS SURGICALGAR2026-03-05
03661522103135CARDIONYL®PETERS SURGICALGAR2026-03-05
14946585347785CROWNJUN Nylon SutureKONO SEISAKUSHO CO.,LTD.GAR2026-03-03
14946585348416CROWNJUN Nylon SutureKONO SEISAKUSHO CO.,LTD.GAR2026-03-03
14946585348423CROWNJUN Nylon SutureKONO SEISAKUSHO CO.,LTD.GAR2026-03-03
14946585348430CROWNJUN Nylon SutureKONO SEISAKUSHO CO.,LTD.GAR2026-03-03
14946585348492CROWNJUN Nylon SutureKONO SEISAKUSHO CO.,LTD.GAR2026-03-03
14946585355292CROWNJUN Nylon SutureKONO SEISAKUSHO CO.,LTD.GAR2026-03-03
04946585357374CROWNJUN Nylon SutureKONO SEISAKUSHO CO.,LTD.GAR2026-03-03
14946585357487CROWNJUN Nylon SutureKONO SEISAKUSHO CO.,LTD.GAR2026-03-03
14946585358002CROWNJUN Nylon SutureKONO SEISAKUSHO CO.,LTD.GAR2026-02-10
14946585042222CROWNJUN Nylon SutureKONO SEISAKUSHO CO.,LTD.GAR2026-01-26
14946585037143CROWNJUN Nylon SutureKONO SEISAKUSHO CO.,LTD.GAR2025-11-13
04946585037153CROWNJUN Nylon SutureKONO SEISAKUSHO CO.,LTD.GAR2025-11-13
14946585041935CROWNJUN Nylon SutureKONO SEISAKUSHO CO.,LTD.GAR2025-11-13
14946585042208CROWNJUN Nylon SutureKONO SEISAKUSHO CO.,LTD.GAR2025-11-13