U.S. IOL, Inc.

Primary DI
00814106016045
Brand
U.S. IOL, Inc.
Company
U.S. IOL, INC.
Model
US-5002LZN
Catalog number
US-5002LZN
Device description
10/0 Micro Spatula, Double-Armed Nylon Suture
Published
2020-09-22
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
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
00814106016052PackageGS112In Commercial Distribution
00814106016045PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00814106016052008141060160528141060160520814106016052
00814106016045008141060160458141060160450814106016045

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 disposable device(s) [e.g., needle, passer] intended to facilitate suture application. 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.

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
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
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
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
00814106016038U.S. IOL, Inc.US-1002LZNUS-1002LZN2020-09-22
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

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