FDA.reportPublic FDA data

L-1248B

Primary DI
10841336100548
Brand
L-1248B
Company
Salvin Dental Specialties, Inc.
Model
L-1248B
Device description
SALVIN 5-0 CHROMIC GUT C3(P3) NEEDLE
Published
2015-10-30
Public version status
Update
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
GALSuture, Absorbable, Natural

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GALSuture, Absorbable, NaturalGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K896554000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K896554000GUT SUTURESLook, Inc.1990-05-31GAL

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10841336100548PackageGS112In Commercial Distribution
00841336100541PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1084133610054810841336100548
00841336100541008413361005418413361005410841336100541

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
113344790
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
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
10841336100647L-1415BL-1415B2015-10-30
10841336100487L-797BL-797B2015-10-30
10841336100494L-560BL-560B2015-10-30
10841336100500L-559BL-559B2015-10-30
10841336100517L-525BL-525B2015-10-30
10841336100524L-558BL-558B2015-10-30
10841336100531L-595BL-595B2015-10-30
10841336100555L-1242BL-1242B2015-10-30
10841336100562L-589BL-589B2015-10-30
10841336100579L-590BL-590B2015-10-30
10841336100586L-554BL-554B2015-10-30
10841336100593L-551BL-551B2015-10-30
10841336100609L-591BL-591B2015-10-30
10841336100616L-592BL-592B2015-10-30
10841336100623L-596B12015-10-30
10841336100630L-594BL-594B2015-10-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00848782052455SharpointSurgical Specialties México, S. de R.L. de C.V.GAL2026-08-26
00840118621410Endure IndustriesENDURE INDUSTRIESGAL2026-08-14
00840118621427Endure IndustriesENDURE INDUSTRIESGAL2026-08-14
00840118621434Endure IndustriesENDURE INDUSTRIESGAL2026-08-14
00840118621441Endure IndustriesENDURE INDUSTRIESGAL2026-08-14
00814639026962Premium UNIFY Fast Gut SuturesAPPLIED DENTAL, INC.GAL2026-08-07
00814639026979Premium UNIFY Plain Gut SuturesAPPLIED DENTAL, INC.GAL2026-08-07
00814639026993Premium UNIFY Plain Gut SuturesAPPLIED DENTAL, INC.GAL2026-08-07
00814639027006Premium UNIFY Plain Gut SuturesAPPLIED DENTAL, INC.GAL2026-08-07
00814639027013Premium UNIFY Plain Gut SuturesAPPLIED DENTAL, INC.GAL2026-08-07
00814639027020Premium UNIFY Chromic SuturesAPPLIED DENTAL, INC.GAL2026-08-07
00814639027037Premium UNIFY Chromic Gut SuturesAPPLIED DENTAL, INC.GAL2026-08-07
00814639027044Premium UNIFY Chromic Gut SuturesAPPLIED DENTAL, INC.GAL2026-08-07
00814639027051Premium UNIFY Chromic SuturesAPPLIED DENTAL, INC.GAL2026-08-07
00848782052417SharpointSurgical Specialties México, S. de R.L. de C.V.GAL2026-07-06
00848782052424SharpointSurgical Specialties México, S. de R.L. de C.V.GAL2026-07-06
00848782052431SharpointSurgical Specialties México, S. de R.L. de C.V.GAL2026-07-06
00848782052448SharpointSurgical Specialties México, S. de R.L. de C.V.GAL2026-07-06
00848782052462SharpointSurgical Specialties México, S. de R.L. de C.V.GAL2026-07-06
00848782052486SharpointSurgical Specialties México, S. de R.L. de C.V.GAL2026-07-06
00848782052684SharpointSurgical Specialties México, S. de R.L. de C.V.GAL2026-07-06
00848782052691SharpointSurgical Specialties México, S. de R.L. de C.V.GAL2026-07-06
00848782052707SharpointSurgical Specialties México, S. de R.L. de C.V.GAL2026-07-06
00848782052714SharpointSurgical Specialties México, S. de R.L. de C.V.GAL2026-07-06
00848782052721SharpointSurgical Specialties México, S. de R.L. de C.V.GAL2026-07-06
00848782052738SharpointSurgical Specialties México, S. de R.L. de C.V.GAL2026-07-06
00848782052745SharpointSurgical Specialties México, S. de R.L. de C.V.GAL2026-07-06
00848782052752SharpointSurgical Specialties México, S. de R.L. de C.V.GAL2026-07-06
00848782052776SharpointSurgical Specialties México, S. de R.L. de C.V.GAL2026-07-06
00848782052783SharpointSurgical Specialties México, S. de R.L. de C.V.GAL2026-07-06