FDA.report

Medline

Primary DI
20080196377197
Brand
Medline
Company
MEDLINE INDUSTRIES, INC.
Model
1423000R
Catalog number
1423000R
Device description
14-23000 ADENOID CURETTE SIZE 0
Published
2022-05-13
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
KBJCURETTE, ADENOID

Product Code Classifications

CodeDeviceSpecialtyClass
KBJCurette, AdenoidEar, Nose, Throat1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
20080196377197PackageGS15In Commercial Distribution
10080196377190PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
2008019637719720080196377197
1008019637719010080196377190

GMDN Terms

TermDefinition
Adenoid curette, single-useA sterile, hand-held manual surgical instrument designed for cutting and excising adenoid tissue (hypertrophic lymphoid tissue in the nasopharynx) during an adenoidectomy (adenectomy). It is typically designed as a long, slender instrument with a handle at the proximal end and a concave, spoon-like tip which has a sharp edge that is used to facilitate the removal of the tissue without causing trauma to the surrounding muscles. It is typically made of high-grade stainless steel and is a common instrument of choice for the removal of the adenoids. This is a single-use device.

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
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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