FDA.report

Richard-Allan® DISPOS-A-PAK

Primary DI
00840113206643
Brand
Richard-Allan® DISPOS-A-PAK
Company
ASPEN SURGICAL PRODUCTS, INC.
Model
3063
Device description
Intent to be used with suture material for tissue closure
Published
2021-02-25
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
true
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
GABNEEDLE, SUTURING, DISPOSABLE

Product Code Classifications

CodeDeviceSpecialtyClass
GABNeedle, Suturing, DisposableGeneral, Plastic Surgery1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00840113206643PackageGS136In Commercial Distribution
00840113206636PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00840113206643008401132066438401132066430840113206643
00840113206636008401132066368401132066360840113206636

GMDN Terms

TermDefinition
Suturing needle, single-useA cylindrical-shaped, solid, metal instrument intended to be used to insert and pull suture material through tissue (e.g., skin, fascia, serous, vascular, or other tissue/organ) during surgical stitching of tissues. It is available in various lengths, curvatures, diameters, cross-sectional shapes, and distal end forms. This is a single-use device.

Sterilization Methods

Method

Contacts

PhoneEmail
+1(616)698-7100customerservice@aspensurgical.com

Regulatory Flags

DUNS number
027680821
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
true
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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10607151001428BOVIEA1204PA1204P2016-10-12
10607151001534BovieA802EUA802EU2016-10-19
10607151001541BOVIEA1252CA1252C2016-10-12
10607151001589BovieA1255AA1255A2016-09-28
10607151002258BovieNLOTNLOT2017-02-10
10607151002579BOVIEA1254CA1254C2016-10-12
10607151004733BOVIEA1202A12022016-10-12
10607151004801BovieFSSEPFSSEP2016-09-16

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
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50192253052334DevonCardinal Health 200, LLCGAB2025-03-27
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20192253052357DevonCardinal Health 200, LLCGAB2025-03-27
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