FDA.reportPublic FDA data

U.S. IOL, Inc.

Primary DI
00814106016120
Brand
U.S. IOL, Inc.
Company
U.S. IOL, INC.
Model
US-9002LZV
Catalog number
US-9002LZV
Device description
9/0 Micro Spatula, Double-Armed PGA 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
GAMSUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K140039000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K140039000POLYCRYLAurolab2014-09-15GAM

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00814106016137PackageGS112In Commercial Distribution
00814106016120PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00814106016137008141060161378141060161370814106016137
00814106016120008141060161208141060161200814106016120

GMDN Terms#

Term, Definition table
TermDefinition
Polyester suture, bioabsorbable, monofilament, non-antimicrobialA single-strand (monofilament), synthetic, bioabsorbable thread made from a polyester (e.g., polydioxanone, poliglecaprone, polycaprolactone, polyglyconate, polyhydroxybutyrate) 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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature2 Degrees Celsius25 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
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
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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Primary DI, Brand, Company table
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08903837799302MonoglydeHEALTHIUM MEDTECH LIMITEDGAM2026-08-19
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10705031472211VICRYLETHICON, LLCGAM2026-08-19
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