U.S. IOL, Inc.

Primary DI
00814106016038
Brand
U.S. IOL, Inc.
Company
U.S. IOL, INC.
Model
US-1002LZN
Catalog number
US-1002LZN
Device description
10/0 Micro Spatula, Double-Armed Nylon Suture
Published
2020-09-22
Public version status
New
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
GARSuture, nonabsorbable, synthetic, polyamide

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K024090000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K024090000NYLON SUTUREAurolab2003-02-28GAR

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00814106016038PackageGS112In Commercial Distribution
00814106016021PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00814106016038008141060160388141060160380814106016038
00814106016021008141060160218141060160210814106016021

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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature2 Degrees Celsius40 Degrees Celsius

Sterilization Methods#

Method table
Method
Ethylene Oxide

Contacts#

Phone, Email table
PhoneEmail
+1(859)259-4925usiol@aol.com

Regulatory Flags#

DUNS number
604739490
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
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00814106015949U.S. IOL, Inc.US-6002-LZNUS-6002-LZN2020-09-22
00814106015963U.S. IOL, Inc.US-7002-LZNUS-7002-LZN2020-09-22
00814106015987U.S. IOL, Inc.US-8002-LZNUS-8002-LZN2020-09-22
00814106016007U.S. IOL, Inc.US-9002-LZNUS-9002-LZN2020-09-22
00814106016021U.S. IOL, Inc.US-1002LZNUS-1002LZN2020-09-22
00814106016045U.S. IOL, Inc.US-5002LZNUS-5002LZN2020-09-22
00814106016069U.S. IOL, Inc.US-6002LZVUS-6002LZV2020-09-22
00814106016083U.S. IOL, Inc.US-7002LZVUS-7002LZV2020-09-22
00814106016106U.S. IOL, Inc.US-8002LZVUS-8002LZV2020-09-22
00814106016120U.S. IOL, Inc.US-9002LZVUS-9002LZV2020-09-22
00814106016144U.S. IOL, Inc.US-8002LZSUS-8002LZS2020-09-22
00803878044721U.S. IOL, Inc.U-BLUEU-BLUE2020-09-22
00814106015956U.S. IOL, Inc.US-6002-LZNUS-6002-LZN2020-09-22
00814106015970U.S. IOL, Inc.US-7002-LZNUS-7002-LZN2020-09-22
00814106015994U.S. IOL, Inc.US-8002-LZNUS-8002-LZN2020-09-22
00814106016014U.S. IOL, Inc.US-9002-LZNUS-9002-LZN2020-09-22
00814106016052U.S. IOL, Inc.US-5002LZNUS-5002LZN2020-09-22
00814106016076U.S. IOL, Inc.US-6002LZVUS-6002LZV2020-09-22
00814106016090U.S. IOL, Inc.US-7002LZVUS-7002LZV2020-09-22
00814106016113U.S. IOL, Inc.US-8002LZVUS-8002LZV2020-09-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07757093013747SUTUMEDUnilene S.A.C.GAR2024-09-19
07757093013891SUTUMEDUnilene S.A.C.GAR2024-09-19
07757093013068SUTUMEDUnilene S.A.C.GAR2023-01-06
07757093013280SUTUMEDUnilene S.A.C.GAR2023-01-06
07757093013563SUTUMEDUnilene S.A.C.GAR2023-01-06
07757093013587SUTUMEDUnilene S.A.C.GAR2023-01-06
07757093013600SUTUMEDUnilene S.A.C.GAR2023-01-06
07757093013877SUTUMEDUnilene S.A.C.GAR2023-01-06
07757093013952SUTUMEDUnilene S.A.C.GAR2023-01-06
07757093014041SUTUMEDUnilene S.A.C.GAR2023-01-06
07757093014096SUTUMEDUnilene S.A.C.GAR2023-01-06
07757093014188SUTUMEDUnilene S.A.C.GAR2023-01-06
07757093014362SUTUMEDUnilene S.A.C.GAR2023-01-06
07757093014393SUTUMEDUnilene S.A.C.GAR2023-01-06
07757093014560SUTUMEDUnilene S.A.C.GAR2023-01-06
07757093014713SUTUMEDUnilene S.A.C.GAR2023-01-06
07757093014744SUTUMEDUnilene S.A.C.GAR2023-01-06
07757093014768SUTUMEDUnilene S.A.C.GAR2023-01-06
07757093014881SUTUMEDUnilene S.A.C.GAR2023-01-06
07757093014898SUTUMEDUnilene S.A.C.GAR2023-01-06
07757093014911SUTUMEDUnilene S.A.C.GAR2023-01-06
07757093015048SUTUMEDUnilene S.A.C.GAR2023-01-06
07757093015093SUTUMEDUnilene S.A.C.GAR2023-01-06
07757093015147SUTUMEDUnilene S.A.C.GAR2023-01-06
07757093015253SUTUMEDUnilene S.A.C.GAR2023-01-06
07757093015277SUTUMEDUnilene S.A.C.GAR2023-01-06
07757093015284SUTUMEDUnilene S.A.C.GAR2023-01-06
07757093015437SUTUMEDUnilene S.A.C.GAR2023-01-06
07757093015482SUTUMEDUnilene S.A.C.GAR2023-01-06
07757093015741SUTUMEDUnilene S.A.C.GAR2023-01-06