FDA.reportPublic FDA data

ELMED

Primary DI
00842180158283
Brand
ELMED
Company
ELMED INCORPORATED
Model
E321526
Catalog number
E321526
Device description
HEMOSTATIC CLIP APPLIER CVD 8'' MED CLIP
Published
2023-01-30
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GDOApplier, Surgical, Clip

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GDOApplier, Surgical, ClipGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00842180158283PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00842180158283008421801582838421801582830842180158283

GMDN Terms#

Term, Definition table
TermDefinition
Ligation clip, metallicA metallic, non-bioabsorbable clasp designed to be implanted around a blood vessel, lymphatic vessel, other tubular anatomy or a tissue bundle, for permanent occlusion. It may be used for ligation in open and endoscopic (e.g., laparoscopic) surgeries; a dedicated, disposable clip applier may be included.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
224-353-6446medical@elmed.com

Regulatory Flags#

DUNS number
049290364
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00842180179219ELMED569556952023-10-05
00198506093876ELMED INCORPORATED9840FS-T9840FS-T2026-08-18
00198506093883ELMED INCORPORATED9841FS-T9841FS-T2026-08-18
00198506093890ELMED INCORPORATED9831FS9831FS2026-08-18
00198506093906ELMED INCORPORATED9835FS9835FS2026-08-18
00198506093913ELMED INCORPORATED9843FS-T9843FS-T2026-08-18
00198506093920ELMED INCORPORATED9844FS-T9844FS-T2026-08-18
00198506093937ELMED INCORPORATEDSTE237820STE2378202026-08-18
00198506093944ELMED INCORPORATEDSTE322424ISTE322424I2026-08-18
00198506093951ELMED INCORPORATED31400-12353HD-OLY31400-12353HD-OLY2026-08-18
00198506093968ELMED INCORPORATED9846FS-T9846FS-T2026-08-18
00198506093975ELMED INCORPORATED25657-1025657-102026-08-18
00198506093982ELMED INCORPORATED22-5200-09F22-5200-09F2026-08-18
00198506093999ELMED INCORPORATEDSTE232825STE2328252026-08-18
00198506094002ELMED INCORPORATED24222-3824222-382026-08-18
00198506094019ELMED INCORPORATED9833FS9833FS2026-08-18
00198506094026ELMED INCORPORATED9842FS-T9842FS-T2026-08-18
00198506094033ELMED INCORPORATED9845FS-T9845FS-T2026-08-18
00198506094040ELMED INCORPORATED9837FS9837FS2026-08-18
00198506094057ELMED INCORPORATEDSTE3230124STE32301242026-08-18

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
14026704928702WECKTELEFLEX INCORPORATEDGDO2026-08-25
14026704928436WECKTELEFLEX INCORPORATEDGDO2026-08-21
14026704928443WECKTELEFLEX INCORPORATEDGDO2026-08-21
14026704928450WECKTELEFLEX INCORPORATEDGDO2026-08-21
14026704928467WECKTELEFLEX INCORPORATEDGDO2026-08-21
14026704928474WECKTELEFLEX INCORPORATEDGDO2026-08-21
14026704928481WECKTELEFLEX INCORPORATEDGDO2026-08-21
14026704928498WECKTELEFLEX INCORPORATEDGDO2026-08-21
14026704928504WECKTELEFLEX INCORPORATEDGDO2026-08-21
14026704928511WECKTELEFLEX INCORPORATEDGDO2026-08-21
14026704928528WECKTELEFLEX INCORPORATEDGDO2026-08-21
14026704928535WECKTELEFLEX INCORPORATEDGDO2026-08-21
14026704928542WECKTELEFLEX INCORPORATEDGDO2026-08-21
14026704928559WECKTELEFLEX INCORPORATEDGDO2026-08-21
14026704928566WECKTELEFLEX INCORPORATEDGDO2026-08-21
14026704928573WECKTELEFLEX INCORPORATEDGDO2026-08-21
14026704928580WECKTELEFLEX INCORPORATEDGDO2026-08-21
14026704928597WECKTELEFLEX INCORPORATEDGDO2026-08-21
14026704928603WECKTELEFLEX INCORPORATEDGDO2026-08-21
14026704928610WECKTELEFLEX INCORPORATEDGDO2026-08-21
14026704928627WECKTELEFLEX INCORPORATEDGDO2026-08-21
14026704928634WECKTELEFLEX INCORPORATEDGDO2026-08-21
14026704928641WECKTELEFLEX INCORPORATEDGDO2026-08-21
14026704928658WECKTELEFLEX INCORPORATEDGDO2026-08-21
14026704928665WECKTELEFLEX INCORPORATEDGDO2026-08-21
14026704928672WECKTELEFLEX INCORPORATEDGDO2026-08-21
14026704928689WECKTELEFLEX INCORPORATEDGDO2026-08-21
14026704928696WECKTELEFLEX INCORPORATEDGDO2026-08-21
14026704928719WECKTELEFLEX INCORPORATEDGDO2026-08-21
14026704928726WECKTELEFLEX INCORPORATEDGDO2026-08-21