FDA.report

ELMED

Primary DI
00842180176744
Brand
ELMED
Company
ELMED INCORPORATED
Model
41028-00
Catalog number
41028-00
Device description
CLIP APPLYING FORCEPS; RANEY, 6-1/4"
Published
2023-08-28
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
GDOApplier, Surgical, Clip

Product Code Classifications

CodeDeviceSpecialtyClass
GDOApplier, Surgical, ClipGeneral, Plastic Surgery1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00842180176744PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00842180176744008421801767448421801767440842180176744

GMDN Terms

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
Moist Heat or Steam Sterilization

Contacts

PhoneEmail
224-353-6446medical@elmed.com

Regulatory Flags

DUNS number
049290364
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
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 DIBrandModelCatalogPublished
00198506089763ELMED INCORPORATED52460-01-H52460-01-H2026-03-24
00198506089770ELMED INCORPORATED52460-02-H52460-02-H2026-03-24
00198506089787ELMED INCORPORATED52460-03-H52460-03-H2026-03-24
00198506089756ELMED INCORPORATED42-191042-19102026-03-23
00198506089695ELMED INCORPORATEDSM-T9931FS-AN-TSM-T9931FS-AN-T2026-03-20
00198506089701ELMED INCORPORATEDSTE5502610ASTE5502610A2026-03-20
00198506089718ELMED INCORPORATEDSTE235920STE2359202026-03-20
00198506089732ELMED INCORPORATEDSTESS572004DSTESS572004D2026-03-20
00198506089749ELMED INCORPORATEDSTESS571004DSTESS571004D2026-03-20
00198506055393ELMED INCORPORATEDSTF9911FSTF9911F2026-03-19
00198506089602ELMED INCORPORATED11126-1111126-112026-03-17
00198506089619ELMED INCORPORATEDSTE3610810600STE36108106002026-03-17
00198506089626ELMED INCORPORATED23-31-040223-31-04022026-03-17
00198506089633ELMED INCORPORATED40-652540-65252026-03-17
00198506089640ELMED INCORPORATED30670-2830670-282026-03-17
00198506089657ELMED INCORPORATED42-170042-17002026-03-17
00198506089664ELMED INCORPORATED38-1093-I38-1093-I2026-03-17
00198506089671ELMED INCORPORATED69127-0369127-032026-03-17
00198506089688ELMED INCORPORATED69127-0269127-022026-03-17
00198506089510ELMED INCORPORATEDSTE11510929STE115109292026-03-13

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
24026704921335WECKTELEFLEX INCORPORATEDGDO2026-03-10
24026704921342WECKTELEFLEX INCORPORATEDGDO2026-03-10
24026704921359WECKTELEFLEX INCORPORATEDGDO2026-03-10
24026704921366WECKTELEFLEX INCORPORATEDGDO2026-03-10
24026704921373WECKTELEFLEX INCORPORATEDGDO2026-03-10
24026704921380WECKTELEFLEX INCORPORATEDGDO2026-03-10
24026704921403WECKTELEFLEX INCORPORATEDGDO2026-03-10
24026704921410WECKTELEFLEX INCORPORATEDGDO2026-03-10
24026704921427WECKTELEFLEX INCORPORATEDGDO2026-03-10
24026704921434WECKTELEFLEX INCORPORATEDGDO2026-03-10
24026704921441WECKTELEFLEX INCORPORATEDGDO2026-03-10
24026704921458WECKTELEFLEX INCORPORATEDGDO2026-03-10
24026704921571WECKTELEFLEX INCORPORATEDGDO2026-03-10
24026704921588WECKTELEFLEX INCORPORATEDGDO2026-03-10
24026704921595WECKTELEFLEX INCORPORATEDGDO2026-03-10
24026704921618WECKTELEFLEX INCORPORATEDGDO2026-03-10
24026704921625WECKTELEFLEX INCORPORATEDGDO2026-03-10
24026704921632WECKTELEFLEX INCORPORATEDGDO2026-03-10
24026704921663WECKTELEFLEX INCORPORATEDGDO2026-03-10
24026704921670WECKTELEFLEX INCORPORATEDGDO2026-03-10
24026704921687WECKTELEFLEX INCORPORATEDGDO2026-03-10
B382SD5715300Surgical DirectSurgical Direct, Inc.GDO2026-03-09
B382SD87531140Surgical DirectSurgical Direct, Inc.GDO2026-03-09
B382SD32155560Surgical DirectSurgical Direct, Inc.GDO2026-02-26
B382SD32155520Surgical DirectSurgical Direct, Inc.GDO2026-02-25
B382SD32155530Surgical DirectSurgical Direct, Inc.GDO2026-02-25
B382SD32155540Surgical DirectSurgical Direct, Inc.GDO2026-02-25
B382SD32155550Surgical DirectSurgical Direct, Inc.GDO2026-02-25
B382SD32152540Surgical DirectSurgical Direct, Inc.GDO2026-02-20
14026704935496WECKTELEFLEX INCORPORATEDGDO2026-02-06