FDA.report

MEDLINE

Primary DI
20197344025210
Brand
MEDLINE
Company
MEDLINE INDUSTRIES, INC.
Model
CISAFE15
Catalog number
CISAFE15
Device description
SCALPEL, SAFETY, DISPOSABLE, STERILE, 15
Published
2024-12-24
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

Related Records

Contact Domains

Product Codes

CodeName
GDXSCALPEL, ONE-PIECE

Product Code Classifications

CodeDeviceSpecialtyClass
GDXScalpel, One-PieceGeneral, Plastic Surgery1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
20197344025210PackageGS110In Commercial Distribution
10197344025213PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
2019734402521020197344025210
1019734402521310197344025213

GMDN Terms

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.

Storage And Handling

TypeLowHighCondition
Special Storage Condition, Specify00NA

Sterilization Methods

Method

Contacts

PhoneEmail
+1(800)633-5463service@medline.com

Regulatory Flags

DUNS number
025460908
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
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

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