FDA.reportPublic FDA data

Symmetry Wieder

Primary DI
00887482032763
Brand
Symmetry Wieder
Company
ASPEN SURGICAL PRODUCTS, INC.
Model
83-6506
Catalog number
83-6506
Device description
Symmetry® Depressor, Wieder Tongue, Large
Published
2024-08-15
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FMADepressor, Tongue, Non-Surgical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FMADepressor, Tongue, Non-SurgicalGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00887482032763PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00887482032763008874820327638874820327630887482032763

GMDN Terms#

Term, Definition table
TermDefinition
Tongue depressor, surgicalA hand-held surgical instrument designed to displace and maintain the tongue in a fixed position, usually by depressing it towards the floor of the mouth. It is typically a metallic (e.g., high-grade stainless steel) device either with a straight shape, or more frequently smoothly bent at its center (e.g., to a 90? arch). The proximal end is used as a handle, while the distal end (usually serrated and may include holes) is used to depress the tongue. The device is used in oral surgery (e.g., during tonsillectomy). This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
1-888-364-7004customerservice@symmetrysurgical.com
+1 888-364-7004customerservice@symmetrysurgical.com

Regulatory Flags#

DUNS number
027680821
Device count
1
DM exempt
true
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00841785102714Symmetry Olsen20-1040I20-1040I2016-09-09
00841785102769Symmetry Olsen20-106020-10602016-09-06
00841785102776Symmetry Olsen20-1060I20-1060I2016-09-06
00841785102899Symmetry Olsen20-108020-10802016-09-06
00841785102905Symmetry Olsen20-1080I20-1080I2016-09-06
00841785102950Symmetry Olsen20-108220-10822016-09-06
00841785102967Symmetry Olsen20-1082I20-1082I2016-09-06
00841785102974Symmetry Olsen20-1082IMT20-1082IMT2016-09-07
00841785103025Symmetry Olsen20-109020-10902016-09-06
00841785103032Symmetry Olsen20-1090I20-1090I2016-09-06
00841785103049Symmetry Olsen20-1090IMT20-1090IMT2016-09-07
00841785103162Symmetry Olsen20-1162I20-1162I2016-09-06
00841785103285Symmetry Olsen20-1190I20-1190I2016-09-06
00841785103667Symmetry Olsen20-1325I20-1325I2016-09-08
00841785103674Symmetry Olsen20-1325IMT20-1325IMT2016-09-08
00841785103735Symmetry Olsen20-1330I20-1330I2016-09-08
00841785103742Symmetry Olsen20-1330IMT20-1330IMT2016-09-09
00841785103803Symmetry Olsen20-1340I20-1340I2016-09-06
00841785103865Symmetry Olsen20-1350I20-1350I2016-09-06
00841785103988Symmetry Olsen20-1360I20-1360I2016-09-06

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
M2207250003Pro AdvantageNATIONAL DISTRIBUTION & CONTRACTING, INC.FMA2025-09-11
M220769000Pro AdvantageNATIONAL DISTRIBUTION & CONTRACTING, INC.FMA2025-09-11
M220770001Pro AdvantageNATIONAL DISTRIBUTION & CONTRACTING, INC.FMA2025-09-11
05010058083608InstrapacROBINSON HEALTHCARE LIMITEDFMA2025-09-11
05010058183605InstrapacROBINSON HEALTHCARE LIMITEDFMA2025-09-11
M220720005Pro AdvantageNATIONAL DISTRIBUTION & CONTRACTING, INC.FMA2025-09-11
M220769003Pro AdvantageNATIONAL DISTRIBUTION & CONTRACTING, INC.FMA2025-09-11
M220770003Pro AdvantageNATIONAL DISTRIBUTION & CONTRACTING, INC.FMA2025-09-11
10080196158744MEDLINEMEDLINE INDUSTRIES, INC.FMA2025-01-17
10080196158768MEDLINEMEDLINE INDUSTRIES, INC.FMA2025-01-17
00887482032756Symmetry WiederASPEN SURGICAL PRODUCTS, INC.FMA2024-08-15
00887482049167Symmetry WiederASPEN SURGICAL PRODUCTS, INC.FMA2024-08-15
00887482049174Symmetry WiederASPEN SURGICAL PRODUCTS, INC.FMA2024-08-15
00884392954451Safety 1stDOREL JUVENILE GROUP, INC.FMA2023-10-15
20884392954455Safety 1stDOREL JUVENILE GROUP, INC.FMA2023-10-15
06973069980023Tongue DepressorDalian Rongbang Medical Healthy Devices Co., Ltd.FMA2023-10-04
16973069980020Tongue DepressorDalian Rongbang Medical Healthy Devices Co., Ltd.FMA2023-10-04
00732094082326Welch Allyn, Inc.WELCH ALLYN, INC.FMA2023-08-17
00810132041150HCSConcordance Healthcare Solutions LLCFMA2023-05-12
00810132041167HCSConcordance Healthcare Solutions LLCFMA2023-05-12
00810132041174HCSConcordance Healthcare Solutions LLCFMA2023-05-12
00810132041181HCSConcordance Healthcare Solutions LLCFMA2023-05-12
10810132041157HCSConcordance Healthcare Solutions LLCFMA2023-05-12
10810132041164HCSConcordance Healthcare Solutions LLCFMA2023-05-12
10810132041171HCSConcordance Healthcare Solutions LLCFMA2023-05-12
10810132041188HCSConcordance Healthcare Solutions LLCFMA2023-05-12
04053755114603DISPOSABLE TONGUE BLADEHeine Optotechnik GmbH & Co. KGFMA2023-01-11
04053755114771TONGUE BLADE HOLDERHeine Optotechnik GmbH & Co. KGFMA2022-12-12
04053755114788TONGUE BLADE HOLDER DISPOSABLE BLADEHeine Optotechnik GmbH & Co. KGFMA2022-12-12
04053755115129TONGUE BLADE HOLDERHeine Optotechnik GmbH & Co. KGFMA2022-12-12