FDA.reportPublic FDA data

Advance Dental Products

Primary DI
00371347011111
Brand
Advance Dental Products
Company
The Atlanta Dental Supply Company
Model
IR-16B
Device description
Cassette, Dual Sided 16 Instrument Holder Set, Blue
Published
2023-12-05
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
false

Product Codes#

Code, Name table
CodeName
FSMTRAY, SURGICAL, INSTRUMENT

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FSMTray, Surgical, InstrumentGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00371347011111PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00371347011111003713470111113713470111110371347011111

GMDN Terms#

Term, Definition table
TermDefinition
Instrument tray, reusableA container intended to provide a suitable platform for placing/containing many medical/surgical/dental instruments and related items for use during a clinical procedure; it might, in addition, be used during, but not dedicated to, reprocessing/sterilization procedures. It is a receptacle in one of a variety of designs, typically with moulded positions for placing the instruments; it might include a lid and/or removable identification tags. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
033505389
Device count
1
DM exempt
true
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
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
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00371347021974Advance Dental ProductsPR018HC2026-01-15
00371347022131Advance Dental ProductsPM018HC2026-01-15
00371347021028Advance Dental ProductsAPT1012026-01-15
00371347021035Advance Dental ProductsAPT1022026-01-15
00371347021042Advance Dental ProductsAPT1032026-01-15
00371347021059Advance Dental ProductsAPT1042026-01-15
00371347021066Advance Dental ProductsAPT1052026-01-15
00371347021073Advance Dental ProductsAPT1082026-01-15
00371347021080Advance Dental ProductsAPT1092026-01-15
00371347021097Advance Dental ProductsAPT1102026-01-15
00371347021103Advance Dental ProductsAPT1112026-01-15
00371347021110Advance Dental ProductsAPT1122026-01-15
00371347021127Advance Dental ProductsAPT1132026-01-15
00371347021134Advance Dental ProductsAPT1162026-01-15
00371347021141Advance Dental ProductsAPT1172026-01-15
00371347021158Advance Dental ProductsAPT1182026-01-15
00371347021165Advance Dental ProductsAPT1202026-01-15
00371347021172Advance Dental ProductsAPT1212026-01-15
00371347021189Advance Dental ProductsAPT1242026-01-15
00371347021196Advance Dental ProductsAPT1252026-01-15

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00850075235070TESA Tensioner SystemTesa Medical, Inc.FSM2026-05-26
00850075235179TESA Tensioner SystemTesa Medical, Inc.FSM2026-05-26
10889950157326Hu-FriedyHU-FRIEDY MFG. CO., LLCFSM2026-05-26
00888118150240PURE PECTUSKLS-Martin L.P.FSM2026-05-25
00888118150257PURE PECTUSKLS-Martin L.P.FSM2026-05-25
00888118150264PURE PECTUSKLS-Martin L.P.FSM2026-05-25
00888118150448IXOSKLS-Martin L.P.FSM2026-05-25
00888118150455IXOSKLS-Martin L.P.FSM2026-05-25
00888118150462IXOSKLS-Martin L.P.FSM2026-05-25
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00888118150486IXOSKLS-Martin L.P.FSM2026-05-25
00888118150493IXOSKLS-Martin L.P.FSM2026-05-25
00888118153029L1 STERNALKLS-Martin L.P.FSM2026-05-25
00888118153050IXOSKLS-Martin L.P.FSM2026-05-25
00888118153067IXOSKLS-Martin L.P.FSM2026-05-25
00888118153074IXOSKLS-Martin L.P.FSM2026-05-25
00888118153081IXOSKLS-Martin L.P.FSM2026-05-25
00888118154613LEVEL ONEKLS-Martin L.P.FSM2026-05-25
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07898663498097HANISCH MEDICALHanisch Medical LtdaFSM2026-03-24
07898663499292HANISCH MEDICALHanisch Medical LtdaFSM2026-03-24