FDA.reportPublic FDA data

Aspen® Flexible Light Handle Adapter

Primary DI
00887761008649
Brand
Aspen® Flexible Light Handle Adapter
Company
ASPEN SURGICAL PRODUCTS, INC.
Model
LT-9534X
Device description
Intent to be used with Aspen Surgical Disposable light Handle covers.
Published
2016-09-17
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
FATBougie, esophageal, and gastrointestinal, gastro-urology

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FATBougie, Esophageal, And Gastrointestinal, Gastro-UrologyGastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00887761008649PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00887761008649008877610086498877610086490887761008649

GMDN Terms#

Term, Definition table
TermDefinition
Light source adaptorA small connecting device designed to permit the connection of the devices that together deliver light to a work field from a light source. This device is used to connect together products of dissimilar manufacture and dimensions, e.g., a fibreoptic light cable of one manufacture to the light source of another. It may also be used at the instrument end. This is a reusable device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(616)698-7100customerservice@aspensurgical.com

Regulatory Flags#

DUNS number
027680821
Device count
1
DM exempt
false
Premarket exempt
false
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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00814707023817Protek1-519-1028B2026-02-16
00840113231867Bard-ParkerST-1002026-02-15
00887482023389Symmetry53-16622026-02-15
00887482023396Symmetry53-16632026-02-15
00887482023402Symmetry53-16642026-02-15
00887482138373Sterion10-00-752026-02-15
00887482156186Symmetry53-1662T2026-02-15
00887482156223Symmetry53-1664T2026-02-15
20887482023376Symmetry53-16612026-02-15
10607151000100BOVIE001000102016-10-10
10607151000117BOVIE001100112016-10-10
10607151000124BOVIE001200122016-10-10
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 DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
G461EGCT400EndolumikEndolumik, Inc.FAT2023-05-15
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24026704719543PILLINGTELEFLEX INCORPORATEDFAT2021-03-11
24026704719550PILLINGTELEFLEX INCORPORATEDFAT2021-03-11
24026704719567PILLINGTELEFLEX INCORPORATEDFAT2021-03-11
24026704719574PILLINGTELEFLEX INCORPORATEDFAT2021-03-11
24026704719581PILLINGTELEFLEX INCORPORATEDFAT2021-03-11
24026704719598PILLINGTELEFLEX INCORPORATEDFAT2021-03-11
24026704719604PILLINGTELEFLEX INCORPORATEDFAT2021-03-11
24026704719611PILLINGTELEFLEX INCORPORATEDFAT2021-03-11
24026704719628PILLINGTELEFLEX INCORPORATEDFAT2021-03-11
24026704719635PILLINGTELEFLEX INCORPORATEDFAT2021-03-11
24026704719642PILLINGTELEFLEX INCORPORATEDFAT2021-03-11
24026704719659PILLINGTELEFLEX INCORPORATEDFAT2021-03-11
24026704719666PILLINGTELEFLEX INCORPORATEDFAT2021-03-11
24026704719673PILLINGTELEFLEX INCORPORATEDFAT2021-03-11
24026704719680PILLINGTELEFLEX INCORPORATEDFAT2021-03-11
24026704719697PILLINGTELEFLEX INCORPORATEDFAT2021-03-11
24026704719703PILLINGTELEFLEX INCORPORATEDFAT2021-03-11
24026704719710PILLINGTELEFLEX INCORPORATEDFAT2021-03-11
24026704719727PILLINGTELEFLEX INCORPORATEDFAT2021-03-11
24026704719734PILLINGTELEFLEX INCORPORATEDFAT2021-03-11
24026704719741PILLINGTELEFLEX INCORPORATEDFAT2021-03-11
24026704719758PILLINGTELEFLEX INCORPORATEDFAT2021-03-11
24026704719765PILLINGTELEFLEX INCORPORATEDFAT2021-03-11
24026704719772PILLINGTELEFLEX INCORPORATEDFAT2021-03-11
24026704719789PILLINGTELEFLEX INCORPORATEDFAT2021-03-11
24026704719796PILLINGTELEFLEX INCORPORATEDFAT2021-03-11
24026704719802PILLINGTELEFLEX INCORPORATEDFAT2021-03-11
24026704719819PILLINGTELEFLEX INCORPORATEDFAT2021-03-11