FDA.reportPublic FDA data

EXEL SCALPELS ,S-S, SIZE:15

Primary DI
10020221295563
Brand
EXEL SCALPELS ,S-S, SIZE:15
Company
Exel International
Model
29556
Device description
EXEL SCALPELS ,S-S, SIZE:15
Published
2023-03-09
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
FMINeedle, Hypodermic, Single Lumen

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FMINeedle, Hypodermic, Single LumenGeneral Hospital2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K895771000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K895771000EXEL SPINAL NEEDLESExel Intl.1990-02-16FMI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10020221295563PackageGS110In Commercial Distribution
20020221295560PackageGS110In Commercial Distribution
30020221295567PackageGS110In Commercial Distribution
00020221295566PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1002022129556310020221295563
2002022129556020020221295560
3002022129556730020221295567
00020221295566000202212955660202212955660020221295566

GMDN Terms#

Term, Definition table
TermDefinition
Scalpel, single-useA hand-held, manual surgical instrument constructed as a one-piece handle and scalpel blade (not an exchangeable component) used by the operator to manually cut or dissect tissue. The blade is typically made of high-grade stainless steel alloy or carbon steel and the handle is often made of plastic. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
180572216
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
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00020221012156Tandem Diabetes 3mL LL WITH CO-PACKED NEEDLE 26Gx3/8’’100121510012152023-04-17
00020221012163Tandem Diabetes 5mL LL WITH CO-PACKED NEEDLE 26Gx3/8’’100121610012162023-04-17
000202210605081 mL sterile syringe SNAP26050SNAP26050SNAP2023-04-04
00020221064483EXEL HYPO NDL 28GX3/4" T.W. 2,000/CS, 100PCS/BOX26448B26448B2023-04-06
00020221260175EXEL 0.3mL INS SYR 28GX1/2"26017260172023-03-20
00020221260199EXEL 0.3mL INS SYR 30GX1/2"26019260192023-03-14
00020221260236EXEL 1/2mL INS SYR 28GX1/2"26023260232024-11-25
00020221260243EXEL 1/2mL INS SYR 28GX1/2"26024260242023-03-15
00020221260328EXEL 1/2mL INS 28GX1/2"26032260322023-03-15
00020221260342EXEL 1mL INS 28GX1/2"26034260342023-03-15
00020221260366EXEL U-40 1/2mL INS SYR 29GX1/2"26036260362023-03-15
00020221260373EXEL U-40 1mL INS SYR 29GX1/2"26037260372023-03-15
00020221260380EXEL 1mL AMBER SYR ONLY LUER SLIP W/ TIP CAP26038260382023-03-15
00020221260458EXEL 1ml SYRINGE 26Gx3/8" L-S26045260452023-03-15
00020221260489EXEL Syringes26048260482016-09-20
00020221260519EXEL 1mL TB 21Gx1"-0-DEAD-SPACE26051260512023-03-15
00020221260564EXEL 1ml Syringe 25Gx1" LDS26056260562023-03-15
00020221260571EXEL 1ml Syringe 23Gx1"26057260572023-03-15
00020221260595EXEL 1mL LDS SYR 20G x 1" LUER LOCK26059260592023-03-15
00020221260601EXEL 1mL ALLERGY SYR 27GX1/2", REGULAR BEVEL26060260602023-03-15

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