MILLENNIUM

Primary DI
00190776327262
Brand
MILLENNIUM
Company
Avalign Technologies, Inc.
Model
2-6630
Device description
Dean Tonsil Knfe,
Published
2023-09-28
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
KBQKNIFE, TONSIL

Product Code Classifications

CodeDeviceSpecialtyClass
KBQKnife, TonsilEar, Nose, Throat1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00190776327262PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00190776327262001907763272621907763272620190776327262

GMDN Terms

TermDefinition
Tonsil knifeA hand-held manual surgical instrument intended for the removal of the tonsils during a surgical intervention. It is typically designed as a one-piece instrument with a sharp, single-edged, scythe-like, cutting blade at the distal end (the internal radius of the curve has the cutting edge) which is normally quite small; it has a very long and slender shaft with a handle at the proximal end. It is normally made of high-grade stainless steel. This is a reusable device.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Contacts

PhoneEmail
+1(877)289-1096product.questions@avalign.com

Regulatory Flags

DUNS number
792528510
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
true

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