FDA.reportPublic FDA data

AESCULAP

Primary DI
04038653207824
Brand
AESCULAP
Company
Aesculap AG
Model
OM150R
Catalog number
OM150R
Device description
Tongue Depressor, blade, depth: 64 mm, non-sterile, reusable
Published
2020-04-22
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
KBLDEPRESSOR, METAL TONGUE, SURGICAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KBLDepressor, Metal Tongue, SurgicalEar, Nose, Throat1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04038653207824PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04038653207824040386532078244038653207824

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(800)282-9000GUDID.BBMUS_Service@bbraun.com

Regulatory Flags#

DUNS number
315018218
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
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
04038653033997AESCULAPDC230RDC230R2020-06-17
04038653034321AESCULAPDE112RDE112R2020-06-17
04038653034369AESCULAPDE116RDE116R2020-06-17
04038653034376AESCULAPDE117RDE117R2020-06-17
04038653034406AESCULAPDE120RDE120R2020-06-17
04038653034901AESCULAPDE676RDE676R2020-06-17
04046963116194S4 CERVICALFW028UFW028U2020-08-24
04046963794248ELAN 4GA768GA7682020-04-24
04046963935184HI-LINE XXSGE813SUGE813SU2020-04-24
04046963935191HI-LINE XXSGE814SUGE814SU2020-04-24
04046963966362ELAN 4GA767GA7672020-04-24
04046964054907ELAN 4GA715RGA715R2020-04-24
04046964076664AESCULAPGE812SUGE812SU2020-04-24
04046964526213ECCOSGB068RGB068R2020-04-24
04038653177035AESCULAPOG963ROG963R2016-09-23
04038653242962AESCULAPDF262RDF262R2020-06-17
04038653339563AESCULAPJG901JG9012025-03-22
04038653345038AESCULAPJG910JG9102020-05-20
04038653038244AESCULAPDP511RDP511R2020-06-17
04038653038251AESCULAPDP512RDP512R2020-06-17

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
09348811004840INKAThe Trustee for KAISER FAMILY TRUSTKBL2025-11-25
09348811004970INKAThe Trustee for KAISER FAMILY TRUSTKBL2025-11-25
00190776407704MillenniumAvalign Technologies, Inc.KBL2025-08-01
00190776407711MillenniumAvalign Technologies, Inc.KBL2025-08-01
00194613046064MSI Precision Specialty InstrumentsMed Saver, Inc.KBL2025-08-01
00194613049324MSI Precision Specialty InstrumentsMed Saver, Inc.KBL2025-08-01
00194613049348MSI Precision Specialty InstrumentsMed Saver, Inc.KBL2025-08-01
00194613049355MSI Precision Specialty InstrumentsMed Saver, Inc.KBL2025-08-01
00194613049386MSI Precision Specialty InstrumentsMed Saver, Inc.KBL2025-08-01
00194613049331MSI Precision Specialty InstrumentsMed Saver, Inc.KBL2025-03-21
00194613107178MSI Precision Specialty InstrumentsMed Saver, Inc.KBL2025-03-21
00841036058838N/ABIOMET MICROFIXATION, INCKBL2024-09-25
00841036073350N/ABIOMET MICROFIXATION, INCKBL2024-09-25
00841036073367N/ABIOMET MICROFIXATION, INCKBL2024-09-25
00887482049150Symmetry Surgical®SYMMETRY SURGICAL INC.KBL2024-08-15
00840183517243BR Surgical, LLCBR Surgical, LLCKBL2024-06-10
00840183521714BR Surgical, LLCBR Surgical, LLCKBL2024-06-10
00840183522858BR Surgical, LLCBR Surgical, LLCKBL2024-06-10
00840183522865BR Surgical, LLCBR Surgical, LLCKBL2024-06-10
00840183525422BR Surgical, LLCBR Surgical, LLCKBL2024-06-10
00840183525736BR Surgical, LLCBR Surgical, LLCKBL2024-06-10
G586E831252ES0Novo SurgicalNOVO SURGICAL, INC.KBL2023-12-18
G586E98312510Novo SurgicalNOVO SURGICAL, INC.KBL2023-12-18
G586E98312520Novo SurgicalNOVO SURGICAL, INC.KBL2023-12-18
G586E98313210Novo SurgicalNOVO SURGICAL, INC.KBL2023-12-18
00842331191930Novo Surgical Inc. NOVO SURGICAL, INC.KBL2023-12-07
00190776049034AvalignAvalign Technologies, Inc.KBL2023-09-28
00190776049041AvalignAvalign Technologies, Inc.KBL2023-09-28
00190776290283MILLENNIUMAvalign Technologies, Inc.KBL2023-09-28
00190776326456MILLENNIUMAvalign Technologies, Inc.KBL2023-09-28