DEVICE: Millennium (00190776399504)

Device Identifier (DI) Information

Millennium
1-351679
In Commercial Distribution

Avalign Technologies, Inc.
00190776399504
GS1

1
792528510 *Terms of Use
Henly Retractor, Improved, straight arms, center & side blades - 3 center blades, sizes: 3/4" (2.2cm), 1" (2.5cm), & 1.25" (3.2cm) deep by 5/8" (16mm) wide - 3 pair of side blades, blunt, sizes: 1" (2.5cm) deep, 2" (5cm) deep, & 3" (7.6cm) deep by 7/8" (2.2cm) wide
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
No
No
No
No
No
No

GMDN

[?]

GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.

GMDN Term Code GMDN Term Name GMDN Term Definition GMDN Term Status [?] Implantable?
45182 Self-retaining surgical retractor, reusable
A hand-operated, self-retaining, one-piece surgical instrument intended to be used to separate/draw aside the margins of a wound/incision to allow access to tissues/organs during open surgery; it is not intended to retract the ribs and is not dedicated to ophthalmic surgery, but may otherwise be clinically dedicated. It is designed as a one-piece device (i.e., not a mounting ring, or table-fixed assembly) having two legs with distal hooked blades and a self-retaining mechanism to maintain the legs in an open position for retraction. This is a reusable device.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
GAD Retractor
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
Yes CLOSE

Sterilization

No
Yes
Sterilization Method [?]
Moist Heat or Steam Sterilization
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Storage and Handling

[?]
Storage and Handling
No storage/handling found
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Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
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Device Record Status

5e77ffd0-99b3-4110-8574-6cea884e8c14
June 09, 2025
1
May 30, 2025
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Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
No Package DIs found
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Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
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Production Identifier(s) in UDI

[?]
Yes
No
No
No
No CLOSE

Customer Contact

[?]
1(877)289-1096
product.questions@avalign.com
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