FDA.report

Aspen®Ruler Bulk

Primary DI
00840113200849
Brand
Aspen®Ruler Bulk
Company
ASPEN SURGICAL PRODUCTS, INC.
Model
2554BN
Device description
Intended to be used as an indicator only and not for accurate measurements
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
false
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
FTYTAPE, MEASURING, RULERS AND CALIPERS

Product Code Classifications

CodeDeviceSpecialtyClass
FTYTape, Measuring, Rulers And CalipersGeneral, Plastic Surgery1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00840113200856PackageGS11In Commercial Distribution
00840113200849PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00840113200856008401132008568401132008560840113200856
00840113200849008401132008498401132008490840113200849

GMDN Terms

TermDefinition
Medical ruler, single-useA small straight-edged strip intended to be used to measure the length of internal or external anatomy, devices or instruments in a clinical setting. It is marked in units of length (i.e., inches, millimetres and/or centimetres), and may be bendable to fit on the measured surfaces. It is not dedicated to wound measurements. 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
true
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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