MILLENNIUM

Primary DI
00190776319625
Brand
MILLENNIUM
Company
Avalign Technologies, Inc.
Model
9-813135
Device description
Needle, Fine,
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
KBRNEEDLE, TONSIL SUTURING

Product Code Classifications

CodeDeviceSpecialtyClass
KBRNeedle, Tonsil SuturingEar, Nose, Throat1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00190776319625PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00190776319625001907763196251907763196250190776319625

GMDN Terms

TermDefinition
Eye spud/needleA hand-held manual ophthalmic surgical instrument intended to be used to remove a foreign body/object embedded in or adhering to the surface of the eye globe. It is typically made of high-grade stainless steel, and designed with a fine handle in the centre of the instrument. At one end is a thin concave blade with a rounded nose (spud), and at the other end is a spearhead-shaped needle. The ophthalmologist uses these tips to remove the foreign body/object. 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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00190776418045Millennium1-161762026-03-23
00190776418052Millennium1-3011172026-03-23
00190776418069Millennium1-4301632026-03-23
00190776418076Millennium72-31578452026-03-23
00190776418267Millennium72-24026202026-03-23

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00194613109752MSI Precision Specialty InstrumentsMed Saver, Inc.KBR2025-03-21
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00190776044077AvalignAvalign Technologies, Inc.KBR2023-09-28
00190776290733MILLENNIUMAvalign Technologies, Inc.KBR2023-09-28
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00190776319885MILLENNIUMAvalign Technologies, Inc.KBR2023-09-28
00190776322281MILLENNIUMAvalign Technologies, Inc.KBR2023-09-28
00190776322298MILLENNIUMAvalign Technologies, Inc.KBR2023-09-28
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